The Effect of Music Therapy on Psychological Status and Sleep Quality Among Pregnant Women

The Effect of Music Therapy on Psychological Status and Sleep Quality Among Pregnant Women: A Randomized Control Trail

There is a strong correlation between sleep disturbance and indications of stress, anxiety, and depression. However, in Egypt no research has looked into how better sleep for expectant mothers might be achieved by inexpensive, pleasurable, non-invasive music listening. Therefore, the aim of this study was to investigate how music listening affects pregnant women's psychological status, and sleep quality.

Study Overview

• Status: Completed
• Conditions: Pregnant Women
• Intervention / Treatment: Behavioral: Music Therapy

Detailed Description

This study used a randomized controlled trial (RCT) design and adhered to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study utilized a simple random sampling technique to select participants in proportion to the total number of pregnant women in the outpatient Medical National Institute in Damanhur city, Egypt.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Nursing, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

In third trimester, 30-34th weeks of pregnancy, age ranging from 18-35 years old, singleton pregnancy, willing to participate

Exclusion Criteria:

having any physical or mental health disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STUDY GROUP; Intervention group Group one (study group, 40 pregnant women): received Music Therapy intervention.	Behavioral: Music Therapy; Music Therapy intervention will be delivered through instructed participants to empty their bladder and then listen to music for 30 min in a semi-fowler's position with their head and shoulders raised 30° in a quiet and dim environment, listening to the music of symphonic music.
Active Comparator: Control group; Group two(the control group, 40 pregnant women):act as a control group/ waiting list	Behavioral: Music Therapy; Music Therapy intervention will be delivered through instructed participants to empty their bladder and then listen to music for 30 min in a semi-fowler's position with their head and shoulders raised 30° in a quiet and dim environment, listening to the music of symphonic music.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression, Anxiety, and Stress Scale	The Depression, Anxiety, and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content.	2 months
Sleep Quality	It is a standardized self-report instrument used to measure the quality and patterns of sleep during the past month. It was developed and validated by Buysse et al. in 1989. It has 9 questions. Question number 5 contains 10 sub-items (from 5a to 5j). All questions are combined to form 7 components. Scoring of answers ranged from zero to three.	2 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): August 20, 2023

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 69-D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No